Published on December 29, 2008
“Generic”Perspectives on the Future of BioSimilars BIOCOM Life Sciences Venture Network San Diego, California February 6, 2008 Michael A. Swit, Esq. Vice President, Life Sciences
Standard Disclaimers •Views expressed here are solely mine and do not reflect those of my firm or any of its clients. •This presentation supports an oral briefing and should not be relied upon solely on its own. 2
Small vs. Large Molecule Realities • Small Molecule • BioSimilar – Therapeutically equivalent – Not therapeutically equiv. • Same molecule • Not same molecule – Substitutable – Not substitutable – Price drives–and multiple – Price difference to brand likely generics drive price down smaller – Insurance coverage follows – Separate coverage likely for the ANDA approval BioSimilar – Marketing –cost sells; little – Will require professional sales and need for formal sales & marketing staffs to drive marketing staff utilization vs. “Brand” – Legal Pathway –clear under – Legal Pathway – Waxman-Hatch Act • 505(b)(2) –case-by-case • PHSA -- nonexistent 3
Therapeutic Equivalence • Lynchpin to generic process –depends on: – 1. Pharmaceutical “ equivalents”–active ingredient, dosage form, strength, etc., must be SAME. • highly unlikely with BioSimilars – – Characterization -- still a challenge even for the innovators –clinical trials may be needed to show comparability after process changes – Chances of “ equivalence”conclusions faint as even a single amino acid can throw off conclusion (e.g., HGH) – Lovenox –only 70% characterized (but, is under an NDA) –no FOP • Janet Woodcock, FDA Deputy Commissioner & CMO (before Congress, March 2007): –“ there is general recognition that the idea of sameness, as the term is used in the generic drug approval process under the Federal Food, Drug, and Cosmetic (FD&C) Act and applied to small molecules, will not usually be appropriate for more structurally complex molecules of the type generally licensed as biological products under the Public Health Service Act.” 4
Therapeutic Equivalence •Lynchpin to generic process –depends on: –2. Bioequivalence study (occasionally clinical studies with efficacy endpoints –e.g., topicals) – •Accurate predictability also allegedly an issue with BioSimilars •Biosimilars –even under an abbreviated pathway, will most likely more resemble an NDA than an ANDA –clinical studies to show efficacy and monitor immunogenicity concerns – Omnitrope® -- Sandoz’ HGH product –rumored to have cost s tens of millions of dollars to develop •This is not your father’ generic model!! s 5
How Omnitrope® Approved • Under 505(b)(2): – Physicochemical testing found highly similar structure to Genotropin – New non-clinical pharmacology and tox data on OMNI itself – PK, PD and comparative bioavailability data – Clinical efficacy and safety data from comparative controlled trials and long-term studies with OMNI – Extensive clinical experience and literature on clinical effects of HGH – Not substitutable –no TE rating 6
Substitutability • Substitution -- core of classic Generic Industry Business Model – Depends on therapeutic equivalence – Allows for “ abbreviated”sales forces – Price drives • Multiple generics common –drives price to commodity status • Biosimilar world – – Substitution -- may evolve, but on a very, very limited basis • Woodcock –must be able to handle repeated brand/follow-in switching without adverse events • HHS –June 2007 letter to Senate HELP Cmte –no interchangeability • Thus, business model will not be multiple generics & not a commodity – Without it, the Generic’ BioSimilar is really a branded drug s • Must be marketed • Will price be enough to drive utilizationf? • Resistance from (a) physicians (b) patients? 7
Price “Delta”–What Will It Be? •Traditional Generic – –First generic -- ± 70% of brand drive price down to commodity –Later generics – •BioSimilar –First “generic”–predicted to be more 10 –30% -- Omnitrope® -- launched at 20% off brand in EU –Later generics – fewer w/Biosimilar; price drops less –If price delta lower, “generic”utilization may be less and slower 8
Reimbursement •Classic generic –is a lay-up; substitution drives •BioSimilar –Not clear; few examples –Different products –not substitution based –Formularies –state and private –will be a battlefield for brand vs. “generic”reimbursement •Efficacy and safety issues –Will payers look for outcomes studies (which could put pressure on both brand and generic)? 9
Marketing Challenges •Classic Generic –substitutability pushes sales •BioSimilar –“Generic”–will have to go out and detail •Costs higher •Not their sweet spot traditionally; although they learn fast (remember, they are used to “ copying” ) •Will they run into greater resistance on “ substitution” from doctors and patients –Innovator –may need to distinguish vs. its “generic” •Internal and external pressure for outcomes studies 10
Legal Pathway •Classic –Waxman-Hatch –Abbreviated NDA and bioequivalence •BioSimilar –505(b)(2) –“ abbreviated,”but limited to those proteins (e.g., HGH, Insulin, hyaluronidase, glucagon, calcitonin, menotropins, ) that cleared under 505(b)(1) and not Public Health Service Act (PHSA) –PHSA –no abbreviated pathway 11
Active Ingredient Issues • Classic Generic –many sources of API • BioSimilar – Technological barriers to API development greater; fewer sources – Foreign sources –particularly from China –will be under great scrutiny from FDA – Immunogenicity concerns are very high – • FDA -- on record that immune response is “impossible to predict” – see Dr. Janet Woodcock, FDA Deputy Commissioner, Congressional Testimony, March 26, 2007 • EU –one-year follow pre-licensing on chronic use products 12
What’ Will 2008 Bring? s • Rumor –Generics waiting for a Democratic President • FDA FY 2009 Budget Proposal: FDA will seek new statutory authority to allow FDA to approve “ abbreviated” applications for certain biologic products licensed under the Public Health Service Act (PHS Act). . . . The proposal will include: … . a predictable and public guidance process for licensing FOPPs. – prescribe data required for FDA to review applications – require labeling for the safety concerns related to interchangeability – adequate intellectual property protections to preserve continued robust – research into new and innovative life-saving medications – user fees • Congress focus: Economy; War –will this happen this year? 13
Post-Legislative Predictions •Iterative process –FDA will be very careful –we are in the post-Vioxx world –Innovators –will seek every possible battle ground to slow BioSimilar approvals •Petitions to FDA on approval criteria and other issues •“Public process”for guidance •Patents – But, don’expect a Waxman-Hatch style process with 180-day t Exclusivity as a reward for challenging patents (although there is a one-year for first “interchangeable”BioSimilar under 2007 legislation not enacted) 14
Ancient Chinese Curse May You Live In Interesting Times … 15
Questions? Call, e-mail, fax or write: Michael A. Swit, Esq. Vice President, Life Sciences THE WEINBERG GROUP INC. 336 North Coast Hwy. 101 Suite C Encinitas, CA 92024 Phone 760.633.3343 Fax 760.454.2979 Cell 760.815.4762 firstname.lastname@example.org www.weinberggroup.com 16
About your speaker… Michael A. Swit, Esq., is Vice President, Life Sciences at THE WEINBERG GROUP, where he develops and ensures the execution of a broad array of regulatory and other services to drug and biologics clients seeking to market products in the United States. His expertise includes FDA and CMS development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts. Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. His multi-faceted experience includes serving for three and a half years as corporate vice president, general counsel and secretary of Par Pharmaceutical, a prominent, publicly-traded, generic drug company and, thus, he brings an industry and commercial perspective to his work with FDA-regulated companies. Mr. Swit then served for over four years as CEO of FDANews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA-regulated community. His private FDA regulatory law practice has included service as Special Counsel in the FDA Law Practice Group in the San Diego office of Heller Ehrman White & McAuliffe and with the Food & Drug Law practice at McKenna & Cuneo, both in the firm’ Washington office and later in San Diego. He first practiced s FDA regulatory law with the D.C. office of Burditt & Radzius. Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the Food & Drug Law Journal Editorial Board, he also has been a prominent speaker at numerous conferences sponsored by such organizations as RAPS, FDLI, and DIA. A magna cum laude graduate of Bowdoin College, he received his law degree from Emory University Law School and is a member of the California, D.C. and Virginia bars. 17
For twenty – five years, leading companies have depended on THE WEINBERG GROUP when their products are at risk. Our technical, scientific and regulatory experts deliver the crucial results that get products to market and keep them there. Washington ♦ New York ♦ San Francisco Brussels ♦ Edinburgh 18
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